Real-World Experience with Calcitonin Gene-related Peptide (CGRP) Antagonists in the Treatment of Migraine

Payal Patel Soni, MD

AHSAM 2020 - Oral session
Published on October 2, 2020 | NEW

7 minute
2 minute

This Medfyle was published more than two years ago. More recent Medfyle on this topic may now be available.

Key messages

  • In clinical trials, calcitonin gene-related peptide (CGRP) antagonists reduced headache frequency and with minimal side effects.
  • In real-world clinical practice, CGRP antagonists demonstrated equivalent efficacy and were well-tolerated but patients reported more common side-effects, such as constipation, than reported in clinical trials.  
  • Further real-world data are needed on the long-term use of CGRP antagonists to provide additional insight on changes in treatment response over time and long-term side effects.
  • Background

    What do we already know about this topic?
  • Findings

    What does this study add?
  • Perspectives

    How does this study impact clinical practice?
  • Expert commentary

    by Morris Levin, MD

Key messages

  • In clinical trials, calcitonin gene-related peptide (CGRP) antagonists reduced headache frequency and with minimal side effects.
  • In real-world clinical practice, CGRP antagonists demonstrated equivalent efficacy and were well-tolerated but patients reported more common side-effects, such as constipation, than reported in clinical trials.  
  • Further real-world data are needed on the long-term use of CGRP antagonists to provide additional insight on changes in treatment response over time and long-term side effects.

Background

What do we already know about this topic?

  • In clinical trials, CGRP antagonists demonstrated a reduction in headache frequency comparable to other preventives and were well tolerated.
  • The real-world effectiveness of CGRP antagonists is unknown.

How was this study conducted?

  • A retrospective cohort study of adult patients (N=336) with a diagnosis of migraine treated with CGRP-antagonists at Cleveland Clinic between May 18, 2018 and December 31, 2018, who had minimum 3 month follow-up.
  • Data collected included age, gender, ethnicity, marital status, pre and post-treatment Headache Impact Test (HIT-6) scores and number of prior failed preventives.
  • Descriptive statistics were calculated for the sample stratified by improvement group; marginal/no improvement, 50%, 75% and 100%.

Findings

What does this study add?

  • Compared to the CGRP-antagonist trials, patients had tried a significantly greater number of preventatives and had higher HIT6 scores at baseline.
  • CGRP-antagonists reduced headache frequency to the same degree as reported in clinical trials.
  • There were no significant differences in demographic data that predicted response to therapy in the episodic and chronic migraine patient groups.
  • While there was a subset of patients who were super-responders and a subset who are non-responders, it does not appear that number of failed preventives, age, or gender are predictive of response to therapy.
  • Side effects, particularly constipation in the chronic migraine group, were more common than reported in clinical trials.

Perspectives

How does this study impact clinical practice?

  • CGRP-antagonists are efficacious and well-tolerated in real-world clinical practice but patients may experience more common side-effects, such as constipation, than reported in clinical trials.
  • Further data will be collected on the long-term use of CGRP-antagonists in the real-world to provide additional insight and monitor changes in treatment response over time and long-term side effects.

Perspectives

How does this study impact clinical practice?

  • CGRP-antagonists are efficacious and well-tolerated in real-world clinical practice but patients may experience more common side-effects, such as constipation, than reported in clinical trials.
  • Further data will be collected on the long-term use of CGRP-antagonists in the real-world to provide additional insight and monitor changes in treatment response over time and long-term side effects.

This is a highlights summary of an oral session given at the AHSAM 2020 Virtual Annual Scientific Meeting and presented by:

Payal P. Soni, MD
Fellow
Cleveland Clinic
Cleveland, Ohio

The content is produced by Infomedica, the official reporting partner of ASHAM 2020 Virtual Annual Scientific Meeting. The summary text was drafted by Goldcrest Medical Writing, reviewed by Marco Vercellino, MD, an independent external expert, and approved by Jessica Ailani, MD, FAHS and Mark J. Burish, MD, PhD, the scientific editors of the program.

The presenting authors of the original session had no part in the creation of this conference highlights summary.

In addition, an expert commentary on the topic has been provided by:

Morris Levin, MD
UCSF Department of Neurology

Morris Levin, MD
UCSF Department of Neurology

Dr Levin is Professor of Neurology at the University of California, San Francisco, where he directs the UCSF Headache Center.  He is also actively involved in research and teaching activities at UCSF.  He is board certified in Neurology with special qualification in Pain Medicine (ABPN).  Dr Levin is also board certified in Headache Medicine (UCNS).

Dr Levin authored a number of medical journal articles and textbook chapters in the areas of headache and pain.  He is the author of Neurology Clinical Case Studies (Anadem 2003), Comprehensive Review of Headache Medicine (Oxford University Press 2008) and Emergency Neurology (Oxford University Press 2013). He is the co-author of Head, Neck and Facial Pain (Anadem 2006), Educational Review Manual in Neurology (Castle Connolly 2006), Headache and Facial Pain (Oxford University Press 2009) and Refractory Migraine (Oxford University Press 2010). He is also the co-author of “Understanding Your Migraines” (Oxford University Press 2017), written primarily for patients and families.

He is an active member of the American Headache Society, where he is on the Board of Directors, and the International Headache Society, where he is chair of the Ethics Committee. He is also a member of the HCOP Board of directors.  He is a Fellow of the AAN, AHS and ANA.

Particular academic interests of Dr Levin include Secondary Headaches, Professional Medical Ethics, and Education in Neurology, Headache Medicine and Pain Medicine. 

Headache
Migraine

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